Clinical Effect of Dialyzable Leukocyte Extract in Suspected or Confirmed Cases of COVID-19 (FUTURE-T) (FUTURE-T)
COVID-19, SARS-CoV-2 Infection
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Dialyzable leukocyte extract, Treatment COVID-19, Treatment SARS-CoV-2 infection
Eligibility Criteria
Inclusion Criteria:
- Adults who agree to participate and sign informed consent.
- Suspected case, according to the operational definition (CONAVE).*
- In the case of confirmed cases, will be those individuals who meet the operational definition of a suspected case and have a confirmed diagnosis by molecular biology, according to the operational definition (CONAVE).**
- The time of acute respiratory symptoms should be no longer than 72h.
- Negative to the rapid test for influenza A/B.
Live in an urban area with easy access for visits.
- Person of any age that has presented at least two of the following signs and symptoms: cough, fever or headache
Accompanied by at least one of the following signs or symptoms:
Dyspnea (signal of severity) Arthralgia Myalgia Odynophagia / pharyngeal burning Rhinorrhea Conjunctivitis Chest pain
**SARS-CoV2 infection confirmed by molecular diagnostic by one laboratory from the National Network of Public Health Laboratories recognized by InDRE.
Exclusion Criteria:
- Pregnancy.
- Evidence of severe acute respiratory infection, even if it meets the criteria for a suspected or confirmed case.
- Hepatic insufficiency
- Diseases that occur with immunosuppression or therapeutic immunosuppression.
- Heart diseases; controlled hypertension is allowed.
- Metabolic diseases; controlled diabetes mellitus is allowed.
- Individuals who have been treated with DLE in the last 6 months.
CONAVE: National Committee for Epidemiological Surveillance. InDRE: Institute of Epidemiological Diagnosis and Reference.
Sites / Locations
- Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Dialyzable Leukocyte Extract
Placebo
Oral administration 2 mg/5 mL every 24 hours for 14 days, following by 2 mg/5 mL twice a week for 3 weeks. All patients will receive paracetamol as symptomatic treatment, 500 mg oral administration 3 times per day.
Oral administration 5 mL every 24 hours for 14 days, following by 5 mL twice a week for 3 weeks. All patients will receive paracetamol as symptomatic treatment, 500 mg oral administration 3 times per day.